Dozens of new cancer drugs do little to improve survival

Marlene McCarthy's breast cancer has grown relentlessly over the past seven years, spreading painfully through her bones and making it impossible to walk without a cane.

Author:
WUSA Staff

Published:
9:23 AM PST February 10, 2017

Updated:
9:23 AM PST February 10, 2017

Marlene McCarthy’s breast cancer has grown relentlessly over the past seven years, spreading painfully through her bones and making it impossible to walk without a cane.

Although the 73-year-old knows there’s no cure for her disease, she wants researchers to do better. It’s been years, she said, since she has found a drug that has actually helped. McCarthy said she’s frustrated that the Food and Drug Administration is approving cancer drugs without proof that they cure patients or help them live longer.

“That simply isn’t good enough,” said McCarthy, of Coventry, R.I. “I understand (why) that could be satisfactory for some people. It isn’t to me.”

Pushed by patient advocates who want earlier access to medications, the­ Food and Drug Administration has approved a flurry of oncology drugs in recent years, giving some people with cancer a renewed sense of hope and an array of expensive new options. A few of these drugs have been clear home runs, allowing patients with limited life expectancies to live for years.

Many more drugs, however, have offered patients only marginal benefits, with no evidence that they improve survival or quality of life, said Dr. Vinay Prasad, assistant professor of medicine at the Oregon Health and Sciences University, who has written extensively about the FDA’s approval process for cancer drugs.

Overall cancer survival has barely changed over the past decade. The 72 cancer therapies approved from 2002 to 2014 gave patients only 2.1 more months of life than older drugs, according to a study in JAMA Otolaryngology–Head & Neck Surgery.

And those are the successes.

Two-thirds of cancer drugs approved in the past two years have no evidence showing that they extend survival at all, Prasad said.

The result: For every cancer patient who wins the lottery, there are many others who get little to no benefit from the latest drugs.

“We are very concerned about the push to get more drugs approved, instead of effective drugs approved,” said Fran Visco, president of the National Breast Cancer Coalition, who said the last game-changing breast cancer drug, Herceptin, was approved nearly 20 years ago.

And those are the successes.

Two-thirds of cancer drugs approved in the past two years have no evidence showing that they extend survival at all, Prasad said.

The result: For every cancer patient who wins the lottery, there are many others who get little to no benefit from the latest drugs.

“We are very concerned about the push to get more drugs approved, instead of effective drugs approved,” said Fran Visco, president of the National Breast Cancer Coalition, who said the last game-changing breast cancer drug, Herceptin, was approved nearly 20 years ago.

In a November study published in JAMA Internal Medicine, researcher Diana Zuckerman looked at 18 approved cancer drugs that didn’t help patients live longer. Only one had clear data showing that it improved patients’ lives, such as by relieving pain or fatigue.

“Our patients need drugs that provide the greatest possible benefit, particularly when you put that in the context of cost,” said Dr. Richard Schilsky, senior vice president and chief medical officer at the American Society of Clinical Oncology, which represents cancer specialists. “You begin to question what is the real value of a therapy when the benefit is small, the toxicity may be similar to a previous drug and the cost is much higher.”

“We cannot have a system where drugs that may not even work are being sold for these amazingly crazy amounts of money,” said Zuckerman, president of the National Center for Health Research, a non-profit in Washington that aims to explain research to consumers.

“We cannot have a system where drugs that may not even work are being sold for these amazingly crazy amounts of money,” said Zuckerman, president of the National Center for Health Research, a non-profit in Washington that aims to explain research to consumers.

Recognizing the slow pace of progress, the American Society of Clinical Oncology has set goals for new cancer drugs of extending life or controlling tumors for at least 2.5 months. The bar was set relatively low because “it’s not very often that we come across a transformative treatment,” said Dr. Sham Mailankody, an assistant attending physician and myeloma specialist at Memorial Sloan Kettering.

Yet in a study published in September in JAMA Oncology, Mailankody found that only one in five cancer drugs approved from 2014 to 2016 met those standards.

Even those slim gains, achieved during carefully controlled clinical trials, can evaporate in the real world, where patients are often older and sicker than those who participate in research studies, said Hanna Sanoff, an associate professor and section chief of the University of North Carolina School of Medicine Gastrointestinal Medical Oncology Program.

Cancer is primarily a disease of aging; 59% of patients are over 65 and 30% are older than 75. Yet only 33% of participants in cancer trials are over age 65 and just 10 percent are over 75, according to a 2012 study in the Journal of Clinical Oncology.

In a study published in September in The Oncologist, Sanoff found that a drug that improved survival in liver cancer by three months offered no survival advantage among Medicare patients outside the clinical trial.

McCarthy, who reviews breast cancer research proposals for the Department of Defense, said she was twice turned down for clinical trials because of her age. When researching experimental therapies, “I’d get excited by something that seemed promising, only to be told I was too old to join the trial, because the cutoff age was 70,” she said.